FORM HS1
Application for approval to
IMPORT OR MANUFACTURE ANY HAZARDOUS
SUBSTANCE FOR RELEASE
under section 28 of the
Hazardous Substances and New Organisms Act 1996
Name of Substance: ROUNDUP POWERMAX
Applicant: MONSANTO Australia Limited
Office use only
Application Code:
Date received:____/____/____
ERMA NZ Contact:
Initial Fees Paid: $
Application Version No: .
IMPORTANT
1.
Before you fill in this application form, you may find it helpful to consult the
User Guide to
Hazardous Substance Applications under the HSNO Act 1996. This User Guide can either be
downloaded from our website or purchased from ERMA New Zealand. The level of information that
you need to provide in this application is dependent upon the scale and the significance of the risks
and/or whether these risks are well understood and controlled. The User Guide will offer further
advice on this.
2.
Part B of the User Guide covers applications under Section 28 of the Act and all of the cross
references in this application form are to Part B.
3.
You can also talk to an applications officer at ERMA New Zealand who can help you scope and
prepare your application. We need all relevant information early on in the application process.
Quality information up front will speed up the process.
4.
This application form may be used to seek approvals for more than one hazardous substance where
the substances are related, for example a concentrated compound (active ingredient) and its related
formulations or the two parts of an epoxy glue.
5.
Any extra material that does not fit in the application form must be clearly labelled, cross-referenced,
and included in an Appendix to the application form.
6.
Commercially sensitive information must be collated in a separate Appendix.
7.
Applicants must sign the form and enclose the correct application fee. The initial application fee can
be found in our published
Schedule of Fees and Charges. Make sure that you have an up to date
copy of the Schedule. Please check with ERMA New Zealand staff. We are unable to process
applications that do not contain the correct fee.
8.
Unless otherwise indicated, all sections of this form must be completed for the application to be
progressed. Where an applicant is unable to complete the sections marked optional, this information
may be derived by ERMA New Zealand and the costs of doing so will be recovered from the
applicant as part of the processing costs.
You can get more information at any time by contacting us. One of our staff members will be able to help
you.
ERMA New Zealand
20 Customhouse Quay
PO Box 131
Wellington
NEW ZEALAND
Telephone: 64-4-473 8426
Facsimile: 64-4-473 8433
E-mail:
[email address]
www.ermanz.govt.nz
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Section One – Applicant Details
See comments under “Section One of Application Form” in the User Guide for guidance.
1.1
Name and postal address in New Zealand of the organisation making the application:
Name:
NEW ZEALAND AGENT
Greg Tower
Monsanto New Zealand Limited
Address:
c/-
Simpson Grierson
Private Bag 92518
AUCKLAND
Phone:
09-358 2222
Fax:
09-307 0331
Email: [email address]
1.2
The applicant’s location address in New Zealand (if different from above):
Address:
92 - 96 Albert Street
AUCKLAND
1.3
Name of the contact person for the application:
This person should have sufficient knowledge to respond to queries and either have the authority to make
decisions on behalf of the applicant that relate to processing the application, or have the ability to go to the
appropriate authority.
Name:
Megan Shaw
Position:
Regulatory Product Manager
Address:
Monsanto Australia Limited
(600 St Kilda Road, Melbourne, 3004)
PO Box 6051
St Kilda Road Central, VIC 8008
AUSTRALIA
Phone:
613 9522 7162
Fax:
613 9525 2253
Email:
[email address]
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Section Two – Application Type and Related Approvals Required
This form is only to be used for an application to import and/or manufacture a hazardous substance for
‘release’ and if it does not meet the requirements for rapid assessment. Please note that it is the substance(s)
which is approved, and thus the approval covers both import and manufacture.
If you
are making the application for some other reason, you will need a different form.
2.1
Is the information in this application relevant to import, manufacture or both:
(See comments under “Section 2.1 of Form” in the User Guide)
Import only?
No
Manufacture only?
No
Import and manufacture?
Yes
If import only, indicate whether or not manufacture is likely in New Zealand
NA
2.2
If the information in the application relates to manufacture in New Zealand, provide
information on the proposed manufacturing process and any alternatives.
(See comments under “Section 2.2 of Form” in the User Guide)
The application is for approval to import and manufacture in New Zealand.
The product is also manufactured in Australia and will be available for importation into NZ. The
manufacture in NZ is envisaged to cover the requirements of the NZ market. The manufacturing
process will be identical to that carried out in Australia and involves a simple blending process of
the technical grade potassium salt of glyphosate in water with a proprietary blend of surfactants
with an anti-foaming agent. Packaging and labelling will be localised on the site of the formulator.
2.3
If you have reasons for not providing detailed information in this application, explain what they
are and provide some justification.
An example of a reason for not giving detailed information is where an approval has been given
by another jurisdiction and information that led to that approval can be referenced or the
substance wil be used in low risk situations or ways.
(See comments under “Section 2.3 of Form” in the User Guide)
2.4
If this substance(s) needs an approval under any other legislation, has an application for this
approval been made?
(Optional) (See comments under “Section 2.4 of Form” in the User Guide)
Name of Approval
Application made
Agricultural Compounds and Veterinary Medicines Act 1997
Yes
Other (please specify):
No
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Section Three – Information on the Substance(s)
Note all information that is commercially sensitive must be attached as an Appendix. The application form
should be cross-referenced to the Appendix but should be able to be read as a stand-alone document which
will be publicly available.
You will need to provide a brief description of where the information in the application has been sourced
from, eg from; inhouse data, research, technical literature, etc. See the introductory comments under
“Section Three of the Form” in the User Guide for more details.
If approval is being sought for more than one hazardous substance, this section must be completed
separately for each hazardous substance.
3.1
State the unequivocal identification of the substance.
This section should include all information necessary to unequivocally identify the
substance(s) and may include:
Chemical Name (Chemical Abstracts Preferred Index name or IUPAC name)
Common Name
Synonyms
MON 78273 Trade Names
ROUNDUP POWERMAX CAS Registry Number
Molecular Formula
Structural Formula
Significant impurities
For mixtures, in addition to the above information being provided on the actual mixture,
information is also required on the composition of the mixture ie the chemical name, CAS
number, function (eg active ingredient, emulsifier, surfactant, filler) and percentages of
ALL components of the mixture (including non-hazardous components and impurities) should be
provided. This information may be best expressed in tabular form. If the composition is
variable, please ensure to state the limits.
If there are commercial reasons for not providing full information in the main part of the form,
alternative approaches must be discussed with and agreed by ERMA New Zealand. These must
include the provision of a unique identifier of some kind.
(See comments under “Section 3.1 of Form” in the User Guide)
For the
CONFIDENTIAL details of the formulation ingredients, refer to Appendix 1.
Ingredient
CAS number
Function
% w/v
glyphosate potassium salt10
70901-12-1
active ingredient
52.0
Compound mixture A11
Compound B12
Compound C13
water
7732-18-5
diluent
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3.2
Provide information on the chemical and physical properties of the substance.
Provide as much information as possible on the chemical and physical properties of the
substance(s) [at 20C and 1 atmosphere unless otherwise stated].
Appearance
viscous liquid
Colour
pale amber
Odour
none
pH
4.8
Density
1.35
Boiling point
1050C
Flashpoint
> 900C
Solubility in water
soluble
For mixtures, information is required on the chemical and physical properties of the mixture itself.
However, if this information is not available, you should provide information on the chemical and
physical properties of EACH hazardous component of the mixture.
3.3 Provide information on the hazardous properties of the substance.
Information should be provided on the hazardous properties of the substance(s)
known to the applicant. You must consider each of the six hazardous properties
below and provide information on those hazardous properties that trigger any
threshold level. If you wish, you may assign the relevant HSNO classification
category to each hazardous property that exceeds these threshold levels.
explosiveness
non-explosive
flammability
non-flammable
oxidising properties
non-oxidising
corrosiveness
non-corrosive
acute toxicity
inhalation toxicity irritation
dermal toxicity sensitisation
non-sensitiser carcinogenic
non-mutagenic/carcinogenic
ecotoxicity
aquatic toxicity / biocidal activity
If your substance is a mixture and you cannot provide direct information on its
hazardous properties, you can apply mixture rules to the hazardous components of the
mixture. If you do this, then you will need to provide information on the hazardous
properties of each hazardous component of the mixture, and show your workings.
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3.3.1 Explosivity
Roundup PowerMax is not an explosive substance according to the criteria set by the
HSNO Act.
3.3.2 Flammability
Roundup PowerMax is not a flammable substance according to the criteria set by the
HSNO Act.
3.3.3 Oxidising
Roundup PowerMax does not oxidise and is not an oxidising or self-reacting substance
according to the criteria set by the HSNO Act.
3.3.4 Corrosiveness
Roundup PowerMax is above the thresholds for having corrosive properties to metal, skin
and eye
.
3.3.5 Toxicity8
Acute toxicity studies are available for a formulated substance (MON 78270) that is very
similar to the substance under evaluation (Roundup PowerMax - MON 78273). The minor
difference between the two formulations is covered in Appendix 1, and relates to the
inclusion of <0.5% of a common food ingredient in MON 78270. The exclusion of this in
the substance MON 78273 under evaluation is considered unlikely to cause any change in
adverse effects. Numerous studies have been conducted on both the active ingredient alone
(glyphosate acid) and the isopropylamine salt formulation of glyphosate. For the potassium
salt of glyphosate (MON 78623)10 that contains no surfactants (compounds A&B)11, the
toxicity values were very similar for both the IPA and K salts. The very low concentrations
of Compounds C and D are unlikely to influence the toxicity of the substance.
The appropriate LD50 mg/kg and LC50 mg/L values for MON 78270 are summarised in the
following table.
Toxicity hazard
MON 78270
Threshold
Classification
acute oral (rat)
>5000 mg/kg 1
not triggered
acute oral (mouse)
>5000 mg/kg 2
not triggered
acute dermal (rat)
>5000 mg/kg 3
not triggered
acute inhalation (rat)
>0.77 <2.21 mg/litre 4
triggered
6.1D
skin irritation (rabbit)
erythema 1.89 5
triggered
6.3B
eye irritation (rabbit)
corneal opacity 0.336
not triggered
conjunctivae 1.336
not triggered
sensitisation (guinea pig)
negative 7
not triggered
acute oral 1,2
Ten male/female rats were tested under OECD guidelines with a single dose of 5000 mg/kg
of formulated material. There was 10% mortality. The LD50 of MON 78270 is indicated to
be >5000 mg/kg.
Similar test on mice showed no mortality with an LD50 of >5000mg/kg. Both of these
values do not trigger the HSNO threshold.
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acute dermal 3
Ten male/female rats were tested under OECD guidelines with a single dose of 5000 mg/kg
of formulated material. There were no longterm effects and no mortality. The LD50 of
MON 78270 is indicated to be >5000 mg/kg. This does not trigger the HSNO threshold.
acute inhalation 4
Under OECD guidelines, two groups of male/female rats received four-hour nose only
inhalation exposure to time weighted average aerosol concentrations of either 0.77mg or
2.21 mg/litre of air. Administration was by aerosol.
There was no mortality at the 0.77 mg/litre concentration. There was 80% mortality at 2.21
mg, the highest dose tested. The LC50 of MON 78270 was therefore indicated to be
between the lowest and highest concentrations tested of 0.77 and 2.21 mg/litre of air. Based
on this range, MON 78270 triggers the inhalation toxicity classification threshold
(HSNO
Classification 6.1D).
skin irritation 5
Rabbits were tested under US EPA / OECD guidelines and EEC methodology to test the
irritant and corrosive effects of a dermal application. Assessments were made at 1, 24, 48
and 72 hours and up to 14 days.
The mean Draize toxicity rating scores were -
Category
Mean Draize test score
HSNO threshold
erythema
1.89
1.5
oedema
0.22
1.5
The calculated FIFRA Primary Irritation index was 2.17 and is therefore considered
moderately irritating. Under the EEC Evaluation Criteria MON 78270 is classified as an
irritant to the skin for erythema and a non-irritant for oedema. Based on the values obtained
MON 78270 triggers the skin toxicity classification threshold
(HSNO Classification 6.3B).
eye irritation 6
Rabbits were tested under US EPA / OECD guidelines and EEC methodology with a single
dose of 0.1ml of substance.
The mean Draize toxicity rating scores were -
Category
Mean Draize test score
HSNO threshold
corneal opacity
0.33
1.0
iris lesion
0.11
1.0
conjunctival redness
1.22
>2.0
conjunctival oedema
1.11
>2.0
Under the EEC guidelines, the material is classified as a non-irritant substance to ocular
tissue.
sensitisation 7
Twenty guinea pigs were treated topically once a week for three weeks. After a two-week
rest period, a single topical re-treatment was made. There were no dermal reactions in the
challenged animals, with a mean rating score of 0.0.
MON 78270 is not a contact sensitiser and therefore does not trigger the HSNO threshold.
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subchronic toxicity
No data is available on the formulated substance. The following table outlines the values in
terms of mg/kg/day measured for glyphosate acid, Compound A and AMPA - the major
metabolite of glyphosate. There appears to be no data available on Compound B. The very
low concentrations of Compounds C and D are unlikely to influence the toxicity of the
substance.
Toxicity study NOAEL
glyphosate acid 14
Compound A14
AMPA14
oral rat (90 day)
209-1445 mg
36 mg
400 mg
mouse
630-2310 mg
rat (2 yr)
409 mg
>2.8 mg
dog
>500 mg (12 mths)
<30 mg (14 wk)
263mg (90day)
developmental rat
1000 mg
15 mg
400 mg
rabbit
175 mg
reproductive rat
694 mg
>4.2 mg
mutagenicity
non-mutagenic
S. typhimurium
negative
E. coli
negative
Summary 14
Results from several investigations establish that the acute toxicity and irritation potential of
(glyphosate IPA formulation) in humans is low. Skin irritation was similar to a baby
shampoo and lower than a dishwashing detergent. There was some potential for skin and
eye irritation from the undiluted substance, but exposure to the water-diluted spray has
rarely resulted in any significant adverse effect. Serious adverse effects such as death
occurred only following deliberate ingestion of large amounts of concentrated substance.
The oral absorption of glyphosate is low and eliminated essentially unmetabolised. Dermal
penetration is low and it does not appear to bioaccumulate in any animal tissue. No
significant toxicity occurred in acute, sub-chronic and chronic studies. Direct dermal
exposure may cause irritation. There is no convincing evidence for direct DNA damage and
it was concluded that the component glyphosate did not pose a risk for the production of
heritable/somatic mutations in humans. Multiple lifetime feeding studies failed to
demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that
glyphosate is non-carcinogenic, not teratogenic or developmentally toxic. There were no
effects on fertility, reproductive parameters, reproductive animal tissues, or any effects
indicative of endocrine disruption.14
Overall, it is concluded that, under the present and expected conditions of use, the current
commercial formulation of the IPA salt of glyphosate containing the POEA surfactant, does
not pose a health risk to humans.14 It is therefore concluded that the toxicity profile of the
proposed substance, which is the potassium salt containing a lower concentration of the
surfactant, would be little different.
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3.3.6 Ecotoxicity
No studies have been conducted on the formulated end use substance for ecotoxic effects.
However, a number of studies have been carried out on glyphosate acid and formulations
containing glyphosate as the isopropylamine salt (IPA). There are fewer studies for the
sodium salt (Na) with a surfactant.
The substance has been designed as a biocide for the non-selective control of a range of
annual and perennial broadleaf and grass weeds.
Surfactants
In practice there are generally four types of surfactants used in glyphosate
formulations. The main one is POEA which has long carbon chains with C16 - C20 carbon
atoms and poor biodegradability. They also have ocular irritancy and aquatic toxicity
properties. The reduction in the concentration of the POEA surfactant in mixture with
another surfactant has reduced ocular irritation effects.
The following table outlines the lowest EC50 or LC50 toxicity values measured for the
substance against the most sensitive of the various test species. Comparison is also made
with the commercial formulation containing the IPA salt of glyphosate that contains a
higher concentration of the polyethoxylated tallow amine (POEA) surfactant than the
substance under evaluation.
Toxicity hazard -
acid 15
IPA +
Na salt + Threshold
Classif.
(glyphosate)
POEA 15
surfact.
indicated
aquatic (mg/L)
fish LC50 96hr
22
5.8
triggered
9.1D
97 (- POEA)
D. magna EC50 48hr
780
9.7
not triggered
930 (-POEA)
S. capricornutum EC50 96hr
21.8
2.6
triggered
9.1D
72.9(-POEA)
soil (mg/kg)
not triggered
earthworm NML 14 days
3750
5000
>125017
NOEC 14 days
118.7
500
27017
DT50 days
2-174
1-197
(geometric mean)
(17)
(arithmetic mean)
(32)
vertebrates (mg/kg)
not triggered
birds LD50 oral
>2000
birds LC50 8 days diet
>4640
>5620
invertebrates (g/bee)
not triggered
honey bee LD50 contact
>100
>100
>2518
biocide
triggered
9.1D
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aquatic
The POEA surfactant in the commercial formulation significantly increases the toxicity to
aquatic organisms. Glyphosate alone as either the acid or technical IPA salt triggered two of
the three HSNO toxicity thresholds that are required for pesticides. There is no data for the
surfactant mixture (compounds A and B).
Glyphosate does not bioconcentrate in fish or other aquatic animals and no significant
bioacumulation is expected.10 The BCF value for the whole bluegill sunfish was <1.10 The
half-life in aerobic water is <7 days.10
Glyphosate and its metabolite AMPA strongly absorb to soil and have a low potential to
leach into ground water.15
soil
Glyphosate tends to bind strongly to soil and particulate matter and is essentially
unavailable to soil organisms. The half-life varies either 1-19715 or 2-174 days with a Koc of
884-60,000 L/kg.10 Although there is an absence of data on the formulated product, and in
particular the surfactant mixture (compounds A and B), it seems that Roundup PowerMax
is unlikely to be significantly different in toxicity compared with the acid and IPA forms of
the active ingredient. Therefore it would not appear to trigger the HSNO threshold.
terrestrial vertebrate/ invertebrate
Apart from the active ingredient glyphosate, there is no extensive scientifically generated
data for the remaining ingredients in relation to terrestrial invertebrate and vertebrate
toxicities. Both glyphosate acid and the commercial IPA salt formulation are practically
non-toxic to birds and honey bees. It appears therefore that Roundup PowerMax would not
trigger the HSNO thresholds for these two categories.
Summary Table
Hazard property
Threshold
Classification category
Explosiveness
not triggered
Flammability
not triggered
Oxidising
not triggered
Corrosiveness
not triggered
Toxicity
acute oral
not triggered
acute dermal
not triggered
acute inhalation
triggered
6.1D
skin irritation
triggered
6.3B
eye irritation
not triggered
sensitisation
not triggered
mutagenicity
not triggered
carcinogenicity
not triggered
Ecotoxicity
aquatic
triggered
9.1D
soil
not triggered
terrestrial vertebrate
not triggered
terrestrial invertebrate
not triggered
biocide
triggered
9.1 D
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3.4
Identification of the default Controls on the substance(s).
A range of default controls are triggered by the hazardous property classification(s) attached to the
substance. If you wish, you can list what these default controls are. If you don’t provide this
information, ERMA New Zealand will do it for you. Regardless, you need to be aware of what the
default controls are so that you can take them into account when assessing risks – see Section 4.
(Optional) (See comments under “Section 3.4 of Form” in the User Guide)
Toxicity:
T 1, 2, 4, 7, 8
Ecotoxicity:
E 1, 2, 6, (E8 ~ T7)
Identification:
I 1, 8, 9, 11, 16 - 21, 28, 29, 30
Packaging:
P 1, 3, 13*
Disposal:
D 4, 5, 6, 7, 8
Emergency Management:
EM 1, 6, 7, 8, 11, 12, 13
3.5 Provide information on what will happen to the substance throughout its whole life from its
introduction into New Zealand, its uses, through to disposal.
This information is used in the development of exposure scenarios and the assessment of risks,
costs and benefits and should therefore be as expansive as possible.
(See
comments under “Section 3.5 of Form” in the User Guide)
Manufacture: The product wil be manufactured by Nufarm Limited at their manufacturing sites in
Melbourne, Australia and Auckland, New Zealand. Importation into New Zealand in plastic lined bulk
containers of 20 thousand litres capacity to the Auckland port. These bulk containers are transported to
the specific local manufacturing site for storage prior to repacking and label ing for retail distribution.
The specific sites are bunded and adopt GMP and the manufacturer has ISO accreditation. Repacking
is carried out according to the Resource Management, Health and Safety to Employee and other
relevant Acts.
Storage: The product is label ed and the smal er size containers are packed in multiple units in
cardboard boxes for despatch to the retailer for storage along with other such products that are
currently used for weed and pest control. The storage and repacking facility has prominent signage
denoting the HAZCHEM code appropriate for the substances in storage. These repacked retail
containers are then despatched to retail outlets and home garden centres etc, to be stored on shelves for
sale to the commercial and domestic end-user.
Packaging: The containers are constructed of HDPE plastic and are very commonly used to contain
pesticides. The label ed containers are either packed in cardboard boxes or shrink wrapped on pal ets
for transportation in bulk to the distributor/retailer for sale as individual units. The pack sizes may
include capacities of 200ml, 500ml, 1, 5, 20, 50, 100, 400 and 1000 litres. The imported container is
20,000 litres in capacity.
Usage: The product is diluted with water It is intended for commercial and home garden use for the
control of a wide range of annual and perennial broadleaf and grass weeds. Little or no contamination
of the local air, soil or water environment is likely as the spraying is directed to the vegetative parts of
the undesirable plants. The claims, instructions and general directions for use are outlined on the
container label.
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Disposal: The container is unlikely to be disposed of until empty. The large 20 thousand litre bulk
container wil be returned empty and unrinsed to the manufacturer in Australia. Similarly, the empty
1000 litre container, general y used by forestry contractors for weed control, wil be returned to the
supplier unrinsed for refil ing and reuse. It is not proposed to refil or reuse the smal er empty container
packs. These are likely to be triple-rinsed with water and disposed of safely by crushing and burning, if
circumstances such as wind direction permit, or buried in a suitable landfil . The smal containers for
home garden use can be disposed of when empty by either recycling or disposal in domestic garbage.
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Section Four: Risks, Costs and Benefits
These are the positive and adverse effects referred to in the HSNO Act. It is easier to regard risks and
costs as being adverse (or negative) and benefits as being positive. In considering risks, cost and
benefits, it is important to look at both the likelihood of occurrence (probability) and the potential
magnitude of the consequences, and to look at distribution effects (who bears the costs, benefits and
risks).
You will need to consider the effects on the environment and human health and welfare, including
any social effects.
In each section set out below, it might be easier for you, and most useful for ERMA New Zealand, if
the information is set out under the following three sub sections:
Costs and benefits which can be stated in monetary (dollar) terms
Non-monetary risks and costs
Non-monetary benefits.
Complete this section as far as you can. If the analysis provided is incomplete, then it will be
completed by ERMA New Zealand. However, the costs of doing this will be chargeable.
You will need to provide a brief description of where the information in the application has been
sourced from, eg from; inhouse research, independent research, technical literature, community or
other consultation.
(See comments under “Section 4 of Form” in the User Guide)
4.1
Identify all of the potential risks, costs and benefits of the substance(s)
Identification is the first step in assessing risks, costs and benefits. The introductory part of
“Section 4 of Form” in the user Guide provides detailed guidance on what kinds of costs,
risks and benefits should be thought about. It is important to think about the source of the
risk, ie the way in which the risk is created (the exposure pathway), and then the
consequences and likelihood of exposure.
You should try to think as widely as possible about every potential risk, cost and benefit and
give a brief description. The range of matters that you will need to think about is discussed
in the User Guide. You must also decide how significant that risk, cost or benefit is likely to
be. If the risk, cost, or benefit is obviously not significant (and you can give reasons), then
there is no need to further assess that risk, cost, or benefit.
(See comments under “Section 4.1 of Form” in the User Guide)
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RISKS - Identification
Source
Lifecycle
Event
Spil age
Transport
Accident during transport and handling - on ship, at port,
Storage
factory site, in land vehicle, to and from storage during life
Use
cycle.
Opening container, measurement of quantity, pouring
into spray tank, and disposal of used container.
Spray application
Use
Contamination of workers, users, the local public; the soil,
Disposal
water and air environments from - the use of un-
calibrated spray equipment, adverse wind causing spray
drift to off-target areas, and disposal of unrinsed
containers.
Hazardous Impact
Exposure pathway
Adverse effect
property
Toxicity
Worker
skin contact
moderate irritation or reddening.
and
inhalation
irritation of respiratory tract
User health
Ecotoxicity
Environment
water - from spil age run-off, effect on aquatic organisms
rinsing and disposal of empty
container.
vegetation - off-target site
biocidal
1.
Primary risk is to Human exposure and its consequences during occupational use.
The risks to human health from exposure to the undiluted substance relates largely to -
Skin contact. Mild irritation with reddening of the skin, especial y from contact with the
undiluted substance.
Inhalation. Inhalation, particularly of the undiluted substance when misted, may give rise to
irritation of the mucous membranes and respiratory tract.
2.
Secondary risk is to contamination of the Environment.
The risks to the environment from exposure would relate to the contamination of -
Water. Slight toxic effects on some fish and aquatic vegetation.
Air. Biocidal effects on off-target areas.
Source of the Risks:
Spillage: Accidental spil age may occur during storage at or transport between the ship, port,
manufacturing site, warehouse, distributor/retailer and the end-user. Accidents in storage situations
could arise from forklift use or improper and unrealistic stacking of containers. Other possible spil age
situations could arise during transportation involving vehicular accidents on public roads or rail. The
physical handling of smal er containers in any situation could also lead to spil age. Spil age is possible at
end-user level during the opening of the container, measuring and pouring the correct amount of the
liquid substance into the spray tank that is partly fil ed with water. Splashes or wind drift of undiluted
substance could occur in these circumstances.
Spray Drift:
Application
to unwanted vegetative plant growth is either by hand operated hand gun,
mistblower and knapsack sprayers, weed wiper, or vehicle operated ground boom sprayer or aircraft.
Al boom spraying equipment would be calibrated to apply specific volumes of diluted spray per
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hectare. Spray drift occurs when adverse wind conditions arise during application, or equipment is
improperly calibrated and spraying pressure is higher than desired. This creates smal fine droplets that
disperse and drift more readily rather than the larger droplets that deposit by gravitational force on to
the surfaces of trees and vines.
BENEFITS - Identification
The major benefit of the substance is the improved toxicity profile in respect of occupational safety to
end-users and the aquatic environment. This fol ows the use of a proprietary blend of surfactants that
reduces the level of the POEA surfactant normal y used which is more ecotoxic with poor
biodegradability. The usual y high concentration of POEA alone gives rise to ocular irritation and
aquatic toxicity.
4.2
Provide an assessment of those risks, costs, and benefits identified in Section 4.1
which might be significant.
This section excludes risks, costs, and benefits which relate specifically to Māori taonga or
to international agreements. See Sections 4.3 and 4.4 below for those aspects.
Assessments only need to be done for those risks, costs and benefits which Section 4.1
shows might be significant. Section 4.2 in the User Guide provides a detailed explanation
of how to do an assessment. Remember that assessments can be qualitative ie based on
judgements, if there is no analytical information available. But it is essential that a firm
conclusion is drawn about the size and likelihood of the risks, costs or benefits, and also
about the certainty of the assessment.
In assessing risks especially, it is important to take account of the extent to which risks will
be reduced by the default or other controls (see Section 3.4 above and 4.5 below).
(See comments under “Section 4.2 of Form” in the User Guide)
RISKS - Assessment
The potential y significant risks with toxic hazardous properties with possible adverse effects on human
health and the environment are considered.
Source of risk
Lifecycle
Occurrence
Impact
Magnitude
likelihood
spil age
transport
unlikely
occupational
minimal
and
health and
storage
environment
use
unlikely
occupational
minimal
health and
environment
spray application
use
unlikely
environment
low
disposal
unlikely
occupational
low
health and
environment
The magnitude of al the risks identified are considered minimal, as they are localised in relation to the
distribution of effects. Application is general y target specific rather than broadcast. Overal , the risks
are considered insignificant. The individual manufactured units wil be contained on pal ets shrink-
wrapped to minimise loss or removal and thus minimise damage and spil age. The geographical
locations are restricted to specific sites whether as the result of any accidental spil age or by use on
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specific weedy areas or individual plants in the home garden. The workers responsible for the handling,
transport and use of the substance are relatively few but are usual y qualified and experienced in such
occupational use. Apart from the deliberate inhalation of the concentrated substance, al risk exposures
are involuntary but can be and are currently managed by controls on packaging, label ing and education.
The long term use of numerous similar glyphosate-based products, both commercial y and
domestical y, has not given rise to any adverse effects.
Spillage -
Accidental spil age during transport and storage is considered unlikely to occur under normal
conditions. Transportation of dangerous goods/hazardous substances is by designated and experienced
carriers such as Chemcourier Services. The use of public passenger or private transport is not
envisaged. Transportation by the end-user from the retailer is unlikely to be private domestic vehicles.
To minimise the possibility of any spil age, the container packaging meets the requirements of
Dangerous Goods for the stability of contents and robustness during handling and storage. The drum
tops have a tamper-proof seal that has a two-fold purpose. One is to be alert to the possibility of
contamination and possible spil age and the other to make it more difficult to access by children. The
major risk of spil age could occur during use by the applicator during the process of measurement and
mixing prior to the spray application. The deliberate act of opening the container by the end-user, and
the consequent measuring/decanting of the correct amount and pouring it into the partly fil ed spray
tank of water, is likely to cause some spil age to a greater or lesser extent.
Impact on Occupational health - spil age during transport or storage would have minimal adverse
effects on individual workers involved. The exposure pathway of the inhalation risk is unlikely to occur.
The low magnitude of any risk to worker health and safety is control ed by the use of suitable protective
clothing such as goggles and rubber gloves. Any exposure to inhalation of the substance is likely to be
of very short duration and therefore of low significance.
Impact on the Environment - spil age during transport is unlikely and in any consequence would be
by nature localised. Current containment procedures would ensure minimal or no contamination of
waterways or drains, and contaminated soil removed to an appropriate approved landfil . Warehouse
storage facilities are general y bunded to ensure containment of any spil age. The spil age can be
absorbed into inert material and disposed of into an appropriate landfil . Some storage facilities may
have underground storage tanks suitable for biological/chemical degradation of waste and spil age.
The spray applications are not made to bodies of water, and any run-off to such from spray drift/
ground deposition would be negligible. Spray applications are made to the point of run-off.
Spray drift -
Spray drift is equal y likely and unlikely to occur, as it is dependent upon the weather conditions
prevailing at and during the spray application. Ground broadcast boom applications are recommended
using low water volumes applied at 200-280 kPa pressure to avoid fine mist droplets. These smal
droplets have the propensity to drift, instead of gravitational deposition upon the target area.
Applications using hand-operated equipment may generate some fine droplets but these are applied
direct to target area. There could be phytotoxic effects from the application to vegetation on the
boundary of treated areas. Home garden applications are directed specifical y and deliberately to the
unwanted vegetation and not applied indiscriminately into the air, onto the ground or towards non-
target areas.
Personnel competency -
Al personnel involve in transportation, storage, and warehousing as wel as end-use have the
knowledge and experience in the handling requirements of hazardous substances previously known as
dangerous goods. Retailers and growers are likely to be GROWSAFE certified with the requisite
knowledge and responsibility in the handling, storage and use of these types of substances.
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BENEFITS - assessment
Benefits-
The introduction of Roundup PowerMax for release into NZ provides an alternative glyphosate-based
herbicide from the originators of glyphosate herbicides. Glyphosate in the form of a different salt
formulated with surfactants of lower toxicity wil give a wider choice where toxicity is a factor. The risk
of adverse effects to occupational health and the aquatic environment is therefore reduced.
Costs-
As a consequence of any spil age during transportation or storage, containment and disposal costs of
contaminated soil and water would occur. The cost of these would depend on quantities of material
involved and the locality of the spil age and the site of an appropriate landfil .
4.3
Provide an assessment of any particular risks, costs and benefits which arise from the
relationship of Māori and their culture and traditions with their taonga, or which are,
for other reasons, of particular relevance to Māori.
We have asked for a separate response in this area because these requirements are different
to other risks, costs and benefits. These are explained in more detail in Section 4.3 of the
User Guide. Please note that if there are potentially significant risks in this area, it will
almost certainly be necessary to consult with Māori in preparing an assessment.
(See comments under “Section 4.3 of Form” in the User Guide)
Overal , the importation and use of Roundup PowerMax wil not adversely affect the natural resources
of indigenous maori flora, fauna, waterways, land and culture. Any effect is minimal and of low
magnitude and is no greater than that pertaining to non-Maori. The controls to be put in place in the
management of the substance would also be applicable in relation to the current health, safety and
culture of maori general y.
The risks are known and understood by Maori by reason of knowledge and experience in the transport
handling, storage and use of glyphosate-based herbicides. Those employed by contractors in the use of
similar types of products would have the appropriate experience and certification of competency to
carry out such duties.
Although virtual y al of the risks are involuntary, the distribution of such are localised geographical y
and are identical to those described for New Zealanders general y under 4.1.
Glyphosate-based herbicides are widely used for the control of unwanted vegetation and used in non-
selective situations, and applied directly to the weed or area infested with weeds. Therefore, it is unlikely
there would be any adverse effects on native flora or traditional food sources such as shel fish,
freshwater fish or herbaceous plants from any incidental or accidental off-target spray or drift. There
does not appear to have been any impact to Maori since the introduction of glyphosate herbicides that
have been in use in NZ for about 30 years.
The introduction of RoundupPowerMax would not violate or impact upon the principles of the Treaty
of Waitangi.
4.4
Provide an assessment of any risks, costs or benefits to New Zealand’s international
obligations.
This is a specialist area which ERMA New Zealand will handle. However, any information
you are able to provide on relevant international agreements would help us and save time
and cost.
(Optional) (See comments under “Section 4.4 of Form” in the User Guide)
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4.5
Provide information on the proposed management of the substance.
This section should provide information on managing the effects identified and assessed in
Sections 4.1 - 4.4 above. The starting point for this is the range of default controls triggered
by the hazardous property classification(s) attached to the substance (see Section 3.4). You
should describe how these controls would be implemented and indicate other mean of
managing risks.. The information provided must be specific to the substance(s) and cover
all areas of intended use. Reference should be made to Codes of Practice or standard
operating procedures that will be followed. If changes to the default controls triggered by
the substance classification are proposed, the reasons for these changes should be provided.
Please note that you will find it easiest to complete this section in conjunction with section
4.2. That is because the management of risks will influence their residual level.
(See comments under “Section 4.5 of Form” in the User Guide)
Identification
The secondary identifiers required to be available within 10 seconds wil include a description of the
hazardous substance, the hazard risks, safety and health warnings and precautions, first aid, disposal
of empty container and rinsate. These wil be prominently displayed at the top of the back panel of
the container label. The name, addresses and phone numbers etc for contact wil also be printed on
the label.
The container wil be label ed before supply for sale, and the label durable for outdoor conditions,
firmly affixed to the container, with text in English that is easily read and understood by a teenager.
The label wil have good contrast between background colour and typeface clarity. The active
ingredient and concentration of the substance wil be described in generic terms. The rates of
application and conditions under which they are permitted to be applied wil be expressed on the
label.
The specific workplace information required within 10 minutes by personnel involved in
transportation, storage, supply, end-use and emergency management is the NZ Material Safety
Data sheet. The data sheet wil include information and controls required for the identification,
description, emergency management and disposal requirements of the substance. The product wil
be stored where signage already exists for the storage of agricultural chemicals with the appropriate
HAZCHEM rating code. Advertising wil indicate the substance is toxic, causing skin irritation
upon contact and must be kept away from children.
Toxicity
The specific requirements of the protective clothing necessary for the handling and use of the
substance wil be contained in the precautionary statements at the top of the back panel of the
label. As the quantities required for the proposed uses are significant, and the product has toxic and
ecotoxic properties, it wil not be transported by private domestic or public passenger transport but
by specific specialist carriers of hazardous goods.
The application equipment wil be calibrated.
Ecotoxicity
The appropriate precautionary statement wil be made on the container label for the avoidance of
contamination of any water supply with the chemical or empty container. Disposal of container wil
be in an approved landfil if not previously crushed and burned.
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Packaging
The substance wil be packed in robust containers for the purpose of secure containment during
the transport by sea from Australia, rail/road within NZ and storage conditions during the product
life cycle.
Emergency Management
The Level 1 information required for managing the risk of any exposure to persons or the
environment is outlined on the container label under Precautions, First Aid and Container disposal.
Additional information relating to contamination from spil age is contained in the Material Safety
data sheet (MSDS).
The Level 2 information required to manage any risk during storage and transportation, in addition
to the container label, wil include the MSDS.
The Level 3 information required for warehouse and other storage facilities wil have the
appropriate signage relative to the quantities stored including the HAZCHEM rating. The
emergency response plan for each storage facility wil be that approved by the appropriate body for
the storage of agricultural chemicals and other deemed hazardous substances. This could include
the local Regional Authority and requirements under the Resource Management Act.
Disposal
The substance is not used undiluted. Dilution is with water only. Rinsate from the triple-rinsing of
the empty containers with water are to be returned to the spray tank. This shal be outlined on the
container label.
The disposal of the rinsed empty container is outlined in bold on the label and conforms to the
general requirements currently accepted under the ACVM Act 1997.
Additional information and documentation requirements in the management of the disposal of
large quantities of undiluted or diluted substance from spil age or expiry wil be outlined in the
MSDS.
Spillage Spil s should be absorbed with inert material and packed in waste containers. Spil s should be
prevented from entering waterways and sewers. Spil age areas should then be washed with water
and the contaminated water and material absorbed with inert material. Disposal of waste and waste
containers must be in accordance with local by-laws. For containment and management of a large
spil age, the Fire Service should be informed immediately and then the local health protection
officer of the local District Health Board or hospital. Details of emergency management are
outlined in the Material Safety Data sheet and also the Agrichemical Hazard Response Handbook
that has been adopted by the NZ Fire Service.
Summary:
The overal management of the substance subsequent to importation or manufacture
for release with controls, in respect of transport, storage, application use and container disposal wil be
in compliance with the Code of Practice for the Management of Agrichemicals NZS 8409:1999. The
information and documentation to facilitate this wil include the ready availability of relevant
documentation such as the container label and Material Safety Data sheet.
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4.6
Provide an overall evaluation of the combined impact of all of the risks, costs and
benefits set out in sections 4.2, 4.3 and 4.4.
Doing this overall evaluation is the main task of the Authority. However, you may wish to
express a view on the relative importance of the different risks, costs and benefits and how
they should be brought together in making a decision.
(Optional) (See comments under “Section 4.6 of Form” in the User Guide)
There are no significant risks in relation to -
Toxicity
Glyphosate is of relatively low oral, dermal and inhalation toxicity. The risk of irritation effects,
particularly skin, from exposure can be managed by appropriate protective clothing such as
goggles and gloves. Studies showed glyphosate did not give rise to mutations or carcinogenic
effects. Some slight effects occurred in developmental studies at very high dose rates. Similarly
in kidneys of male rats at high doses in reproductive studies, but was not mutagenic. Almost all
the glyphosate is excreted as parent compound, with very little absorbed in tissues and organs,
and less reaches the bone marrow.
Dietary exposure
The EPA concluded that chronic dietary risk posed by glyphosate food uses is minimal. A
reference dose or estimate of daily exposure that would not cause adverse effects throughout a
lifetime of 2 mg/kg/day has been proposed. This is based on the developmental toxicity
studies.14 Human dietary exposure and risk is therefore minimal.
Occupational exposure
Exposure to workers is generally expected to pose no undue risks, due to its low acute toxicity.
However, splashes during measuring and mixing may cause eye and skin irritation. Protective
clothing would minimise the effect of this exposure risk.
Environmental exposure
Glyphosate is absorbed strongly to soil and does not appear to move below the 15cm soil layer,
with residues expected to be immobile in the soil. It is readily degraded by soil microbes to the
metabolite AMPA that in turn is degraded to carbon dioxide. It is not readily broken down by
water and sunlight.
Glyphosate is not toxic to birds, earthworms and honey bees, but is classified (under HSNO) as
slightly toxic to some fish species. The risk of exposure to aquatic organisms can be managed
and minimised by ensuring disposal of container rinsate into spray tank and the subsequent
burning or burial of empty containers in a landfill.
Maori
Providing the substance is used according to current and proposed label instructions, there is
unlikely to be any adverse effects on the flora, fauna and other taonga associated with Maori.
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Section Five – International Considerations
5.1
ERMA New Zealand is interested in whether this substance (or any of its components) has
been considered by any other regulatory authority in New Zealand or by any other country.
If you are aware of this, please provide details of the results of such consideration.
(Optional) (See comments under “Section 5.1 of Form” in the User Guide)
New Zealand
Other commercial formulations containing glyphosate as the active ingredient have been
considered by the Ministry of Agriculture both under The Agricultural Chemicals Act 1959 and the
subsequent Pesticides Act 1979. Of the 63 currently registered products to date containing
glyphosate, a selection of some of these products with the active ingredient in a soluble concentrate
formulation, is outlined in the following table.
This comparison is made with the proposed soluble concentrate formulation of Roundup
PowerMax containing 40% glyphosate (540g/litre).
Trade name
Registrant
Active
Register
Date
content
No.
registered
(g/litre)
Roundup Ultra
Monsanto Australia Limited
510
P5844
Oct 2001
Roundup Renew Xtra
Monsanto Australia Limited
490
P5628
March 2000
Roundup Herbicide
Monsanto Australia Limited
360
P5014
Oct 1998
Australia
The registration of the identical formulation by the NRA in Australia is pending. The application is
under the same trade name Roundup PowerMax (CRIS 55687).
USA
Glyphosate was discovered by Monsanto and developed commercially in about 1972.
The US EPA have previously considered and approved the sodium salt of glyphosate under the
trade name of Polado. The registration was for use as a plant growth regulator on sugar cane. The
US EPA have registered a similar formulation (MON78270) under the trade name Roundup
WeatherMax herbicide.
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Section Six – Miscellaneous
6.1
Provide a glossary of scientific and technical terms used in the application.
(See comments under “Section 6.1 of Form” in the User Guide)
AMPA
amino methyl phosphonic acid (metabolite of glyphosate)
GMP
Good Manufacturing Practice
HAZCHEM code
Hazardous Chemical Emergency Response code
HDPE
high density polyethylene
ISO
International Standards Organisation
NML
no-mortality level
POEA
polyethoxylated tallow amine (surfactant)
SAR
Structure Activity Relationship
6.2
Provide here any other information you consider relevant to this application not already
included.
(See comments under “Section 6.2 of Form” in the User Guide)
Nil
Section Seven – Summary of Public Information
The information provided in this section may be used in the Authority’s public register of
substances required under Section 20 of the HSNO Act.
This summary information will be used to provide information for those people and agencies (eg
Ministry for the Environment, Department of Conservation, Regional Councils, etc), who will be
notified of the application, and for potential submitters who request information. This information
will also be used to prepare the public notice of the application.
For these reasons, applicants should ensure that this summary information does not contain any
commercially sensitive material.
7.1 Name of the substance for the public register:
Roundup PowerMax
7.2
Purpose of the application for the public register:
The purpose of the application is to obtain approval to import and manufacture for release
of Roundup PowerMax for use as a herbicide for the control of weeds in non-selective
situations. The inhalation toxicity, dermal irritation and ecotoxic/biocidal activity triggers
the HSNO thresholds for a hazardous substance.
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7.3
Use Categories of the substance:
ERMA New Zealand has adopted the system of use categories developed by the European Union,
which identify various functional uses of substances. This information is pertinent to the
assessment of exposure scenarios and the determination of risk and is also useful for building up a
profile of the substance. There are three sets of use categories. Within each of these, applicants
should state which use categories are relevant to all intended uses of the substance.
Main category: 4 Wide dispersive use - spraying of a pesticide.
Industry category: 1 Agricultural industry - plant protection product.
Function/Use category: 38 Pesticide - destroy undesirable plants
7.4
Executive Summary:
In this section, the applicant should provide a summary of information contained in this application,
including:
the identification of the substance, its hazardous properties and intended uses
an assessment of the risks, costs and benefits
the methods implemented to manage the risks, particularly in relation to emergency
management and disposal.
This is an application to import and manufacture Roundup PowerMax for release in NZ for use as a
herbicide. The product contains glyphosate as the active ingredient in a soluble concentrate
formulation for dilution with water. The active ingredient is of low acute toxicity and is not
mutagenic or carcinogenic. The substance is classified as hazardous by reason of its low inhalation
toxicity, skin irritation and aquatic toxicity. It is designed as a biocide for use by farmers,
commercial horticultural growers and foresters for the control of a range of annual and perennial
broadleaf and grass weeds.
The large empty imported bulk container will be returned to the manufacturer. The smaller retail
containers, when empty, will be triple rinsed, crushed and burned or buried in a suitable landfill.
The concentration of active ingredient in the water-based formulation will have little or no adverse
effect to handlers and users during transport, storage and end use, or to the air and soil
environments around the treated plants.
Glyphosate is not active long term in the soil or plant environments.
It poses little risk to humans when the material is handled and used according to the label
instructions. This is confirmed by the widespread usage of the substance in various formulations
since its introduction into New Zealand in the early 1970's.
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CHECKLIST
Mandatory sections filled out
Yes
Appendices enclosed
Yes
Fee enclosed
Yes
Application signed and dated
Yes
Electronic copy emailed to ERMA NZ
Yes
Signed
Date
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